Access to health data: the EU gets started

The inability to access the vast health data sets being captured through Europe’s disparate healthcare systems is one of the major obstacles to digital health research. Data privacy rules accord special protection to health data, and are themselves implemented in a fragmented and inconsistent manner between Member States. The more closely the problem is examined, the less tractable it seems to get.

The European Commission has nonetheless decided to bite the bullet and try to find a way to harness the power of this resource. The Staff Working Document which accompanied the January 2017 Communication Building a European Data Economy explained that the objective of the Communication is to identify the most effective ways to:

Improve access to anonymous machine-generated data;

Facilitate and incentivise sharing of data;

Protect investment and assets;

Avoid disclosure of confidential data; and

Minimise lock-in effects.

The ultimate mechanism may be either legislative or non-legislative. The former could include: default contract rules; access for public interest purposes (along the lines of the new French model) and a new data producer’s right either as a right in rem or as a defensive right including the right to sue third parties (a right in possession rather than ownership, and potentially subject to an obligation to license). Non-legislative measures might include: guidance on how to share data safely within the current legislative framework to lower transaction costs; fostering the development of technical solutions for reliable identification, exchange and differentiated access to data; and/or model contract terms.

The Commission is also thinking about the impact of data portability provisions as a means for enhancing access to data but is aware that this may hinder enterprises in achieving the essential network effect.

It has now launched a consultation to collect information on three main pillars as regards health and care in the Digital Single Market. The topics of interest are:

Citizens’ secure access to their health data and the possibility to share it across borders; clarifying citizens’ rights and enhancing interoperability of electronic health records in Europe;

Connecting and sharing data and expertise to advance research, personalise health and care, and better anticipate epidemics; and

The Commission is expressly seeking input from the widest range of interested parties, from patient organisations, health and care professionals, public authorities and researchers to industries, investors, insurers and users of digital health tools.